OPMI PENTERO OPMI PANTERO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-21 for OPMI PENTERO OPMI PANTERO * manufactured by Carl Zeiss, Inc..

Event Text Entries

[1272148] During a surgical procedure (thoracic laminectomy for syrinx) a suspected burn developed at the incision site, and after investigation and research, it is possible the reaction may be due to a combination of the heat from the microscope's xenon light source, the use of duraprep and the ioban antimicrobial drape. There was no ignition or charring of the drape. The nurse circulating in this case states that at the conclusion of the case, upon removal of the ioban drape, it appeared that the skin looked somewhat red, and the ioban drape was difficult to remove. There was some discussion between the surgeon, the pa, and the nurse related to the integrity of the skin and whether or not it warranted more attention at that time, but according to the nurse in the room it was determined that there was no serious damage that they observed at the time. A dry, sterile dressing was applied and the patient had a two day stay. The microscope use in the case was less than 30 minutes. There was no charring, fire or drape ignition. The light of the microscope was 50% and the circle was restricted to the intradural area of microsurgery. It is not clear that the skin lesions are light related burns. Equally possible is a chemical burn from the dura-prep. Healing is progressing quite well. There have been no additional surgeries required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1417983
• MDR Report Key: 1417983
• Date Received: 2009-05-21
• Date of Report: 2009-05-21
• Date of Event: 2009-03-24
• Report Date: 2009-05-21
• Date Reported to FDA: 2009-05-21
• Date Added to Maude: 2009-07-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OPMI PENTERO
• Generic Name: MICROSCOPE, SURGICAL
• Product Code: EPT
• Date Received: 2009-05-21
• Model Number: OPMI PANTERO
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARL ZEISS, INC.
• Manufacturer Address: ONE ZEISS DRIVE THORNWOOD NY 10594 US 10594

Device Sequence Number: 2

• Brand Name: IOBAN
• Generic Name: DRAPE, SURGICAL
• Product Code: KKX
• Date Received: 2009-05-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: 3 M HEALTH CARE
• Manufacturer Address: 3M CENTER BLDG 275-4W-02 ST. PAUL MN 55144100 US 55144 1000

Device Sequence Number: 3

• Brand Name: DURAPREP
• Generic Name: SURGICAL PREP SOLUTION
• Product Code: KOY
• Date Received: 2009-05-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: 3M HEALTH CARE
• Manufacturer Address: 3M CENTER BLDG 275-4W-02 ST. PAUL MN 55144100 US 55144 1000

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2009-05-21